NDC 72162-2231
Mesalamine 1.2 g tablet, delayed release
On the label: Bryant Ranch Prepack. It's repackaged: Bryant Ranch Prepack rebottles it from Actavis Pharma, Inc.'s NDC 0591-2245.
Where the pills inside were made
This label doesn't name the factory that makes the drug. Companies don't have to print it on the label. The maker's name is often on the stock bottle your pharmacy used; you can ask the pharmacist. See the plants Actavis Pharma, Inc. names for other drugs.
Repackaging site
- Bryant Ranch Prepack, Burbank, CA, United States · repackages it and relabels it
Recalls
- Oct 28, 2020 · Class II · Teva Pharmaceuticals USA
Failed Dissolution Specifications: Out-of-specification dissolution results were obtained during stability testing.
Lots: Lot #s: 1342498A, Exp. 12/2020; 1342499A, Exp. 01/2021; 1354638A, Exp. 03/2021; 1354639A, 1358274A, 1358448A, 1364618A, 1369884A, Exp. 05/2021; 1366195A, 1369885A, 1373570A, Exp. 06/2021; 1373571A, Exp. 07/2021; 1388571A, Exp. 01/2022; 1395725A, 1396585A, 1397550A, 1399389A, Exp. 04/2022; 1403885A,… - Feb 20, 2020 · Class II · Teva Pharmaceuticals USA
Failed Dissolution Specifications: Low out of specification dissolution result observed during stability testing.
Lots: Lot #: 1342500A, Exp 10/2020
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mesalamine: every company that makes it
- Form
- tablet, delayed release, oral
- Strength
- 1.2 g
- Approval
- ANDA ANDA203817
- On the market since
- Mar 26, 2018
- Package NDCs
72162-2231-2- Official label
- DailyMed (National Library of Medicine), updated Aug 14, 2024
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